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PubMed1993

The climacteric kaleidoscope: questions and speculations.

This call for a review of climacteric research, its present trends and methodologies, is not prompted so much by mounting criticism from many quarters as by personal disappointment. Despite increasing research we have not achieved the understanding which, not long ago, seemed so near: we have sadly failed in convincing women (and their medical advisers) we can help them and, worse, we have 'departmentalized' ourselves from the concurrent scourge of cancer of the breast. It is here suggested that some of these aims, indeed a greater understanding of the place of fertility in female life, may be achieved by a reexamination of biological baselines. It is proposed we look again at the evolutionary strategems protecting the young, enquire into ethological/sexual hominoid relationships and reevaluate the biorhythm of repeated pregnancies. It is especially the latter, culturally so unacceptable in societies in which women limit their families and menstruate, that offers new venues for research. For, once seriously considered, without bias, it may help in devising means by which we can retain our way of life, free of the dangers inseparable from avoidance of pregnancy and loss of the benefits of its hormones.

Animals↗
PubMed1993

A novel oestradiol--desogestrel preparation for hormone replacement therapy: effects on hormones, lipids, bone, climacteric symptoms and endometrium.

Desogestrel is a strong progestogen with low androgenicity which has so far been used only in oral contraceptives. We studied the feasibility of administering desogestrel in combination with oestradiol as hormone replacement therapy (HRT). Thirty women received a sequential combination containing 1.5 mg micronised oestradiol (24 days) and 0.15 mg desogestrel (last 12 days of cycle) for 6 months. At that stage 6 of the women dropped out; the remaining 24 were studied for a total of 12 months. The treatment alleviated vasomotor symptoms effectively in all the women and induced regular withdrawal bleeding in 86% of them. Secretory changes were observed in the endometria of 16 of the 20 women with adequate endometrial samples assessed after 12 months of treatment. No signs of hyperplasia or atypia were found. Six months of treatment resulted in a decrease in the mean serum follicle-stimulating-hormone concentration from 66.2 (+/- 4.3, S.E.M.) to 23.3 (+/- 3.1) IU/l and a rise in the oestradiol and sex-hormone-binding globulin concentrations from 87.9 (+/- 13.7) to 233.1 (+/- 20.4) pmol/l and from 52.1 (+/- 4.6) to 70.2 (+/- 5.6) nmol/l, respectively. Testosterone levels decreased. There were significant reductions in serum total and low density lipoprotein (LDL) cholesterol and triglycerides. After 12 months of treatment high-density lipoprotein (HDL) cholesterol values did not differ significantly from the pretreatment levels. The HDL/LDL and HDL/total cholesterol ratios increased. The treatment reduced bone turnover as indicated by decreases in bone alkaline phosphatase and osteocalcin serum levels and by lowered urinary calcium/creatinine and hydroxyproline/creatinine ratios. An increase of about 2% in forearm bone mineral density was also observed. This new oestradiol-desogestrel preparation therefore appears to be a promising alternative form of HRT. It alleviates climacteric symptoms effectively, exhibits favourable effects on serum lipids and lipoproteins and prevents bone loss.

Bone Density↗
PubMed1995

The climacteric among South-American women, who immigrated to Sweden and age-matched Swedish women.

Forty-nine immigrated South-American (SA) and 48 Swedish women, aged 42-67 years, were studied in a comparative semi-structured interview survey, concerning the climacteric and its treatment. The mean age at natural menopause was 47 for the South-American women and 50 for the Swedish women. The prevalence of moderate to severe vasomotor symptoms at the time of the survey did not differ significantly between the non-treated, non-operated, postmenopausal South-American and Swedish women (36% and 21%; N.S.). One reason for the trend towards a higher prevalence among South-American women could be that a greater number of Swedish women used hormone replacement treatment compared to South-American women (11 vs. 4). The general attitude to hormone replacement therapy was more positive among South-American women, although they did not use hormone therapy, as could be expected from their symptoms. These results are probably an illustration of the difficulties in getting access to treatment for the immigrated SA women.

Adult↗
PubMed1995

Tibolone and climacteric symptoms.

Tibolone (Livial) has advantages over other forms of hormone replacement therapy (HRT); it is easy to use and does not induce withdrawal bleeding in postmenopausal women. The evidence for the effect of tibolone on climacteric symptoms is reviewed and shows that tibolone is effective in reducing vasomotor symptoms and vaginal dryness. Tibolone's effect on a range of other symptoms such as headache and insomnia is unclear. There are reports that tibolone improves mood and libido but much of this research is methodologically flawed. Methodologically sound research is required to investigate tibolone's effect on mood and libido; such a study is in progress.

Climacteric↗
PubMed1996

A randomized, double-blind, multicentre study comparing the clinical effects of two sequential estradiol-progestin combinations containing either desogestrel or norethisterone acetate in climacteric women with estrogen deficiency symptoms.

OBJECTIVES: The aim of this study was to compare a new estradiol-desogestrel (E2-DG) regimen with an E2-norethisterone acetate (NETA) combination (Trisekvens) regarding the treatment of menopausal complaints, bleeding pattern, histology of the endometrium and the occurrence of adverse experiences. METHODS: A total of 310 peri-/postmenopausal women with climacteric symptoms were randomly allocated to oral sequential treatment with either the E2-DG combination (1.5 mg E2 for 24 days with 0.15 mg DG for the last 12 days followed by 1 placebo tablet for 4 days) or with the E2-NETA combination (Trisekvens, 2 mg E2 for 22 days with 1 mg NETA for the last 10 days followed by 1 mg E2 for 6 days). Treatments were administered double-blind for 12 cycles of 28 days. RESULTS: One hundred and four women, 48 in the E2-DG group and 56 in the E2-NETA group, discontinued the study due to bleeding irregularities and various adverse effects. Both treatments reduced menopausal symptoms and complaints effectively and almost equally. The alleviation of perspirations and the improvement of general fitness were more apparent (P = 0.009) during cycle 1 with the E2-NETA treatment but were greater (P < 0.02) during the last 9/10-12 cycles of E2-DG treatment compared to E2-NETA. Regular withdrawal bleeding appeared in 93% and 90% of the women during treatment with E2-DG and E2-NETA, respectively. Intermenstrual bleeding occurred in 8% of women receiving E2-DG and in 13% of women treated with E2-NETA. The corresponding figures for intermenstrual bleeding-spotting were 21% and 22%. Secretory endometrium was detected in 65% and 54% of the samples taken at the end of treatment with E2-DG and E2-NETA, respectively. No hyperplasia or atypia was found. No serious adverse events related to treatment occurred. CONCLUSIONS: Both regimens alleviated effectively menopausal complaints and did not induce hyperplasia of endometrium. The minor differences recorded between the two regimens were probably due to the differences in their composition concerning the amount of estradiol and its distribution along the cycle, the amount and type of progestin and the length of estradiol/progestin combination phase.

Administration, Oral↗
PubMed1982

Psychological changes effected by estrogen-progestogen and clonidine treatment in climacteric women.

The psychological responses of 23 symptomatic climacteric women were analyzed to compare the effects of opposed estrogen therapy, i.e., conjugated equine estrogen (Premarin) and medrogestone (Colpro), with those of clonidine (Dixarit). Ten asymptomatic postmenopausal women constituted a control group. Statistical analysis of the data of this randomized double-blind prospective study showed that the hormone-treated group experienced significant improvement in various measurements of depression and anxiety whereas the clonidine-treated group did not. Ratings based on subjective reports by the patients support these findings. Various inverse and positive associations between the psychological variables are presented.

Affective Symptoms↗
PubMed1999

Contraceptive status and sexual function of climacteric Chinese women.

The objective of the present survey was to assess the contraceptive status and sexual function of climacteric Chinese women. One cross-sectional study randomly recruited 742 premenopausal, perimenopausal, and naturally menopausal women aged 45-55 years from Beijing. Contraceptive methods were used by 75.6% of premenopausal and 54.2% of perimenopausal women. The primary methods were the IUD and barrier method. The women's choices of methods were related to parity and frequency of sexual activities. Sexual activity was related to the satisfaction of contraceptive methods. Perimenopausal and postmenopausal women were about half as likely to enjoy sexual activity and to experience orgasms than premenopausal women. Women of higher socioeconomic status had a lower risk for decreased sexual functioning. The IUD was the most popular and the most appropriate contraceptive method for perimenopausal women. Sexual function was associated with the women's satisfaction with the contraceptive method used, their menopausal status, and their socioeconomic class.

China↗
PubMed1978

Relation between plasma oestrone and oestradiol and climacteric symptoms.

Plasma levels of oestrone and oestradiol-17beta were determined at 20 or 30 minute intervals for up to 24 hours in 26 postmenopausal or ovariectomised women of similar age, weight, and number of years since menopause or operation. Results in women with both superficial dyspareunia and flushes were compared with those in women with flushes only, and with those in symptomless women. Women with superficial dyspareunia had significantly lower mean concentrations of plasma-oestradiol, but not of oestrone, than symptomless women. Flushes were not related to plasma-oestrogen. The implications of these findings in relation to the optimum dose of oestrogen for treating climacteric symptoms are discussed.

Adult↗
PubMed1979

Prevention and treatment of endometrial disease in climacteric women receiving oestrogen therapy.

The treatment regimens are described in 74 patients with endometrial disease among 850 climacteric women receiving oestrogen therapy. Cystic hyperplasia was associated with unopposed oestrogen therapy without progestagen. Two courses of 21 days of 5 mg norethisterone daily caused reversion to normal in all 57 cases of cystic hyperplasia and 6 of the 8 cases of atypical hyperplasia. 4 cases of endometrial carcinoma referred from elsewhere demonstrated the problems of inappropriate and unsupervised unopposed oestrogen therapy and the difficulty in distinguishing severe hyperplasia from malignancy. Cyclical low-dose oestrogen therapy with 7--13 days of progestagen does not seem to increase the risk of endometrial hyperplasia or carcinoma.

Adenocarcinoma↗
PubMed1998

Counselling of the climacteric woman. Diagnostic difficulties and therapeutic possibilities.

The psycho(patho)logical disorders during climacteric can only be adequately diagnosed and treated if the gynaecologist also pays clinical attention to the biographically related adaptation troubles of the woman in (peri)menopause. Psychoneurotic and psychosomatic reactions are frequent; psychotic reactions are rarely seen. The anxiety neuroses of this age of life are triggered less by sexual factors, but more by angry impulses. This anxiety can be expressed in a paranoid behaviour. Most adaptation difficulties and psychiatric disorders during menopause can and should be effectively treated by the gynaecologist. Theoretical understanding and practical experience concerning the counselling of psychosomatic patients are indispensable.

Adaptation, Psychological↗
PubMed2001

Clinical evaluation, dose-finding and acceptability of AERODIOL, the pulsed estrogen therapy for treatment of climacteric symptoms.

S21400 (AERODIOL) is a new intranasal formulation of 17beta-estradiol. It provides a pulsed estrogen therapy that ensures sufficient estrogenisation of tissues to treat estrogen deficiency symptoms, particularly those of the menopause. This multicentric study was designed to determine dose-range, efficacy and acceptability of S21400. One hundred and thirty four women were allocated a daily dose of 100-900 microg for 12 weeks. The doses of 100, 600 and 900 microg were given in two daily administrations, the doses of 200, 300 and 450 microg were given in one and two daily administrations. Oral progestogen was added the last 10-14 days of each cycle of estrogen therapy in all non-hysterectomized women. S21400 showed a dose-effect relationship and provided adequate estrogenisation in more than 80% of patients receiving a dose ranging from 200 to 600 microg daily. Hormonal impregnation was judged sufficient in 23% of women receiving the lowest dose (100 microg). It was often considered excessive for daily doses of 900 microg (36%). After 12 weeks of treatment, efficacy was similar whether the total daily dose was given in one or two administrations. Treatment was well tolerated and accepted, with only minor nasal events (prickling, sneezing). It was perceived by 92% of patients as good or excellent and 81% chose to continue the nasal treatment when it was offered to them. An initial dose of 300 microg per day provides an optimal efficacy/tolerability ratio. In summary, the pulsed estrogen therapy with AERODIOL in one daily administration offers a safe, well accepted and highly effective treatment to alleviate climacteric symptoms. It can be adapted easily to ensure optimal clinical efficacy.

Administration, Inhalation↗
PubMed2004

Soy isoflavones and melatonin for the relief of climacteric symptoms: a multicenter, double-blind, randomized study.

OBJECTIVE: To evaluate the effect of soy isoflavones and melatonin in relieving menopausal symptoms. METHODS: Double-blind, multicenter, randomized trial performed according to a 2 x 2 factorial design. Treatment groups: (1) soy isoflavones+melatonin; (2) soy isoflavones alone; (3) melatonin alone; (4) placebo. 80 mg of soy isoflavones, 3 mg of pure melatonin or placebo were supplemented to participants for 3 months. Severity of menopausal symptoms was recorded at baseline and after 3 months using the Greene Climacteric Scale. RESULTS: 388 consecutive women were screened: not eligible 98, refused informed consent 28. Randomized 262 and analyzed 232; twelve women withdrew because of adverse events. Median percent differences between basal and final scores were 39% in the isoflavones + melatonin group, 38% in the isoflavones alone group, 26% in the melatonin alone group and 38% in the placebo group. Placebo response was much higher than planned, making it meaningless to perform any statistical test. With regard to somatic and vasomotor symptoms, outcome was similar among the four groups, whereas improvement of psychological symptoms was higher in the isoflavones+melatonin group than in the other three. CONCLUSIONS: Present data do not show any advantage of isoflavones or melatonin over placebo for the relief of menopausal symptoms. However, the effect in psychological symptoms in the isoflavones + melatonin group should be further investigated.

Adult↗
PubMed1997

Womens attitudes and knowledge about the climacteric period and its treatment. A Swedish population-based study.

OBJECTIVES: The aim of the study was to investigate womens knowledge and attitudes about the menopause and hormone replacement therapy (HRT). MATERIAL AND METHODS: Women aged 46, 50, 54, 58 and 62 years, born on uneven days, resident in Göteborg, Sweden (n = 5.990) were invited by letter to complete a questionnaire concerning the menopause and HRT. RESULTS: The response rate was 76% (n = 4504). Current estrogen use was reported by 21%. Another 20% had stopped estrogen use e.g. because of a fear of cancer (9%) or other side-effects (14%). The most common reasons to refrain from HRT were minor climacteric symptoms (27%), fear of cancer (9%) or side-effects (15%) and the opinion that the menopause is a natural process (20%). A majority (67%) preferred HRT without withdrawal bleedings, especially elderly women (80%). Thirty-five per cent could accept life-long HRT if treatment was free from withdrawal bleedings. Almost 70% received their information about the menopause and HRT from a physician. Forty-five percent of the women considered the menopause to be a relief. Approximately 60% had a regular sex-life. The most common reasons for not having a regular sex-life were irrespective of the womans age, the absence of a partner (43%). Loss of sexual desire (29%) or partners loss of desire (12%), both of which showed an increase with age, were other reasons given. Only 8% of the total population had no sexual activity because of vaginal dryness but in the oldest cohort (62 years old) 32% gave this as a reason. CONCLUSION: Physicians require more time for counselling of patients about the menopause and HRT. Many women refrain from therapy because of fear and misconceptions. To achieve better long-term compliance especially in elderly women the use of 'non-bleeding' regimes requires further attention.

Age Factors↗
PubMed2000

Determinants of age at menopause in Italy: results from a large cross-sectional study. ICARUS Study Group. Italian Climacteric Research Group Study.

OBJECTIVE: To identify the determinants of age at menopause in an Italian population, using data from the Italian Climacteric Research Group Study (ICARUS). METHODS: ICARUS is a prospective study of the effect of menopause on women's health that has been running in menopause clinics throughout Italy since 1995. A total of 4300 women with spontaneous menopause, aged 55 years or more and observed for the first time at the participating centres are included in the present analysis. RESULTS: The mean age at menopause in the total population was 50.9 years. After taking into account potential covariates, the women reported smoking, had a slightly lower mean age at menopause than non smokers 50.4 versus 50.9 years; P = 0.01. The mean age at menopause in nulliparae was 50.0 years, and, respectively 50.4, 50.6, 50.9, 51.2 and 50.9 years in those reporting 1, 2, 3, 4 and 5 or more births (P < 0.01). A low body mass index and an early age at menarche were associated with early menopause in the crude analysis, but these associations disappeared after taking into account the confounding factors. CONCLUSIONS: This study offers an estimate of the mean age at menopause of women attending menopause clinics in Italy, on the basis of the data obtained from a large sample. It also indicates that smoking and nulliparity are associated with early menopause.

Age Factors↗
PubMed1977

The role of oestrogen replacement in the climacteric syndrome.

Using a double-blind placebo-controlled cross-over design, the effect of equine conjugated oestrogens tablets (Premarin) was studied in 20 women with the climacteric syndrome followed during 15 months. Sixteen women were equally improved on placebo and oestrogen. Only 2 patients had an improved sense of well-being on oestrogen and not on placebo. The psychological diagnosis was unrelated to the subjective response to oestrogen or placebo. Performance in psychological tests administered before and during treatment periods was not changed by oestrogen or placebo.

Adult↗
PubMed2000

[Climacteric syndrome].

The most frequent symptoms of the climacteric syndrome are hot flushes. Although usually they disappear after a few years, hot flushes persist for five or more years in a quarter of the affected women. Aetiology and pathomechanism are not clear. Apart from oestrogen deficiency other diseases should be evaluated as potential causes of hot flushes such as psychosomatic disorders, hyperthyroidism and a neoplasm. The treatment of the first choice is an oestrogen replacement therapy. By assaying a single serum sample for oestradiol an oestrogen replacement therapy can be monitored reliably only in the case of transdermal application.

Administration, Cutaneous↗
PubMed2000

[Sexuality in the climacteric].

Women undergo during the pre- and postmenopausal period typically a large number of physical and psychosocial changes that have an influence on sexual desire and on the sexual response cycle. The individual experience, the emotional and cognitive coping with these changes as well as the resulting behavioral patterns show a great interindividual variability. Nevertheless, some general characteristics can be summarized: Sexual activity is declining, but not necessary sexual satisfaction. The most common complaints are dyspareunia and lack of libido. The conditioning factors are multiple: on one hand endocrine factors, whose influences are most important in peripheral sexual organs especially the vaginal mucosa and although present somehow less important in the central nervous structures; on the other hand psychosocial factors, where partner interactional patterns and the individual learning history of sexuality play the most important roles. This knowledge has to be integrated into sexual counselling for climacteric women and their partners.

Aged↗
PubMed2000

Efficacy on climacteric symptoms and safety of low dose estradiol transdermal matrix patches. A randomized, double-blind placebo-controlled study.

Two estradiol (E2) transdermal patches releasing 25 micrograms/day E2 (D-25) or 37.5 micrograms/day E2 (D-37.5) were compared to a placebo patch on 156 patients in natural or surgical menopause suffering from at least 5 hot flushes per day, randomly and blindly assigned to three parallel groups of 52 patients each, to be treated continuously for 12 weeks, without progestin opposition. "Responders" (patients with less than 3 hot flushes per day at the end of treatment), were 82% and 90% under D-25 or D-37.5, respectively, both significantly (p < 0.001) more than under placebo (44%). Comparable efficacy was observed on severity of hot flushes, Kupperman Index and on the self-rated efficacy. Systemic adverse events occurred in 10%, 10% and 8% of patients, respectively, under D-25, D-37.5 or placebo. Occasional mild and transient itching and/or erythema on the site of application was reported by few patients and did never require discontinuation of application. In conclusion D-25 and D-37.5 were significantly more effective than placebo in relieving climacteric symptoms and were systemically and locally as well tolerated as placebo. D-25 (Demestril 25) releasing 25 micrograms/day E2 can therefore be recommended for low-dosed estrogen replacement therapy.

Administration, Cutaneous↗